Quality Assurance Management

Resume

Over my career, which launched in ****; I decided to…

Keep my attitude above my knowledge and increasing my career scope to be qualified and eligible, from both technical point of view and personnel traits point of view.

Give all attention and listening to my leaders, free reading and continuing education are my legal and ethical tools.

Date of birth : 3/8/1985.

Place of birth : Egypt.

Marital status : Married.

Military status : Completed.

Driving license : Available.

Mobile : 011********.

E-mail : sherifsalama **********@*****.***.

Address : 25-saad zaghlol st., Hehia city, Alsharkeya governorate, Egypt. Degree: BSC of Microbiology at May 2007.

Grade : Good.

Faculty: Science, Suez Canal University.

Course / Study

University / Educational

center

From To Grade

Lead Auditor FSSC (ISO 22000 +ISO TS 22001) SGS (Accredited from IRCA) 5/2016 5/2016 Lead auditor Diploma of TQM including the following

courses:

1- Quality System Standards

ISO 9001/2008 (QMS)

ISO 14001/2004 (EMS)

ISO 19011/2011 (AMS)

Documentation Management System

Baldrige Award Management System

2- Planning For Top Quality

3- Statistical Quality Control

4- The Basic Six Sigma (Yellow Belt)

5- Project Management

6- Managing Quality Function

Leadership, Ethics & Benchmarking

Employee Empowerment

Supply Chain Management System

AUC 3/2014 4/2015 Excellent

Pre –Master of microbiology Zakazik university 8/2011 8/2012 Good GMP course & pharmacovigilance Internal training in Otsuka 4/2011 5/2011 Attend Diploma of microbiology Suez canal university 8/2008 8/2009 Good Sherif Abd-elhamid Elsayed Salama

Personal Details

Contact Information

Basic Education

High Education &Courses

I. From 1/7/2015 till now at “OTSUKA” multinational company for Pharmaceuticals Industries (Sterile Manufacturing Processes) as quality assurance (QA) Act as supervisor. a) Participate, Lead & supervising team responsible for handling the following processes:- Deviation, CAPA, change control, complaint, internal audit, risk assessment, recall and ensure effectiveness of these processes by continues measuring its operation against standards, guidelines and SOPs through KPIs and continually improving and updating them.

b) Preparing semiannual and annual reports including our coming priorities according to the statistical analysis for data collected from previous processes to present it to top management based on which the new objectives will be assigned and implemented.

c) Liaison with suppliers, service providers and external parties and participate in preparing for, coordinating and following external audits conducted by statutory and regulatory parties as MOH, ISO certification body and other customers as GSK, MUP, Sanofi Aventis and Pfizer… d) Participate in problem solving and root cause analysis for raised deviations and follow CAPA implementation and measuring its effectiveness.

e) Define training needs and train all staff on previous processes through effectively prepared training materials as power point, work shop and other training tools then evaluate and assess training impact in reality. f) Participate in validation activities ( as HVAC validation, Sterile room validation, Cleaning Validation, SIP validation, media fill test ….) and issue, review validation documentation system (as Validation protocol, report)

g) Batch Record Review

II. From 1/7/2012 till 30/6/2015 at “OTSUKA” multinational company for Pharmaceuticals Industries (Sterile Manufacturing Processes) as quality assurance (QA) senior. III. From 1/7/2010 till 30/6/2012 at “OTSUKA” multinational company for Pharmaceuticals Industries (Sterile Manufacturing Processes) as quality assurance (QA) inspector a) Inspect warehouses (RM & FP) and production lines/areas (Raw material receiving, dispensing, preparation, filling, inspection, packaging, and distribution) for GMP compliance and other approved quality standards. b) Controlling tablet IPC tests as friability, disintegration, hardness, thickness and weight variability. c) Check sampling and testing of product during product life cycle according to approved sample plans. d) Complete and maintain quality and production records according to GMP and other quality standards. e) Check the facility and personnel hygiene and sanitation status. f) Equipment and measurements:-

Integrity test IT4 for testing filter integrity

Met one device for measuring particle count

Smoke test & Dop test

LUX meter for measuring light intensity

TSI for measuring air velocity

Check Point for measuring O %

Dry fog for room sterilization

Work Experience

From 1/2/2010 till 31/6/2010 at “ABBOTT” multinational company for Pharmaceuticals industries as medical representative.

a) Responsible for marketing of blood-glucose monitoring system “FREE STYLE” in hospitals and private clinics.

From 1/5/2009 till 30/1/2010 at “SKIVA” company for Pharmaceuticals industries as medical representative. a) Responsible for marketing of cosmetic and pharmaceutical products. Computer Skills: Excellent computer skills including Microsoft office (word, PowerPoint, excel and Minitab statistical tools.

Language Skills:

Arabic (Native Language)

English (Pass Standards English Proficiency Test “SEPT” in AUC at Feb 2014). Free reading in different disciplines as ICH, GMP Manual, Food Safety Management System, ISO 18001, HACCP, Kaizen, 5S, Brain storming…

Letter of Appreciation from Otsuka for me as member of the team who was responsible for the planning, executing and operating the new ampoule project which involve adding two lines for 5 ml and 25 ml WFI ampoules. My role in the project from the quality assurance point of view is to managing process validation including media fill process and normal production process and also controlling compliance of produced units or ampoules with specifications

(volume, weight, thickness, crack, leak preparing trends, control charts, other graphs and statistical tools and also qualification of the new loop which extended to the preparation and filling of the new project

Have high observation skills

Decision making skills

Dynamic and ambitious

Ability to work under pressure and in a team work

Patience and self confidence.

Time management skills.

Problem solving skills

“All documents are available and ready just up on request” Skills

Self Education

Honors & Awards

Other Qualifications

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